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Drugs

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Drug Safety

 Title and Format  Type  Issue Date
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (PDF - 1516 KB)

Final

 2/2005
Drug-Induced Liver Injury:  Premarketing Clinical Evaluation (PDF - 206 KB)
Final
 7/29/2009
Drug Safety Information - FDA's Communication to the Public (PDF - 114 KB)
Final
 3/2/2007
Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS),
REMS Assessments, and Proposed REMS Modifications (PDF - 316 KB)		 Draft 9/30/2009
Postmarketing Studies and Clinical Trials — Implementation of
Section 505(o) of the Federal Food, Drug, and Cosmetic Act (PDF - 173 KB)		 Draft 7/15/2009
    
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